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Stock impact report

Orchard Therapeutics Receives Positive CHMP Opinion for Libmeldy™ for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD)

Orchard Therapeutics plc - American Depositary Shares (ORTX) 
Last orchard therapeutics plc - american depositary shares earnings: 2/27 07:00 am Check Earnings Report
Company Research Source: GlobeNewswire
First therapy recommended for full marketing authorization in the EU for eligible patients with confirmed diagnosis of late infantile or early juvenile MLD variants One-time treatment with Libmeldy has been shown to preserve cognitive and motor function in most patients Libmeldy is backed by data across 35 patients with follow-up of up to 8 years post-treatment, demonstrating the potential durability of HSC gene therapy BOSTON and LONDON, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene), an investigational gene therapy for the treatment of metachromatic leukodystrophy (MLD), characterized by biallelic mutations in the ARSA gene leadi Show less Read more
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